DE69831027T2 - Devices for removing soft tissue - Google Patents

Description

Territory of invention

The The present invention relates to tissue sampling devices and in particular, improved sampling instruments and methods of soft body tissue.

background the invention

It is often desirable and often necessary to take a part of human or animal tissue or to test, especially in the diagnosis and treatment of patients with cancerous Tumors, premalignant states and other diseases or disorders.

Usually In the case of breast cancer, emphasis is placed on early detection and early diagnosis by applying screening methods, such as Body examinations, and especially mammography, with the very small, often non-palpable abnormalities can be recognized. If the doctor uses a mammogram or other screening method, determines that there are suspicious circumstances must have one Biopsy performed be to tissue for to take a definitive diagnosis as to whether the suspicious lesion is cancerous. A biopsy can be performed by an open or percutaneous method. In open biopsy, an invasive surgical procedure with a scalpel and direct view of the target area is the whole mass (excisional biopsy) or part of the mass (incisional biopsy) away. A percutaneous biopsy, however, is usually with a needle-like Instrument through a relatively small cut blind or with help an imaging device and can either a Fine needle aspiration (FNA) or a core biopsy. At a FNA biopsy becomes single cells or cell clusters for cytological Taken and can study for example, be prepared in a Papanicolaou smear. Core biopsy, as the name implies, becomes a nucleus or fragment of the tissue taken for histological examination, what about a frozen section or paraffin section can be done.

The Type of biopsy applied especially from the circumstances of the patient, including the location of the lesion (s) in the body, and not a single procedure is ideal in all cases. The core biopsy however, is extremely useful in a number of conditions and is used by the medical profession frequently used.

One very successful type of image-guided core percutaneous core biopsy instrument currently available is a vacuum-assisted automatic core biopsy device. One such successful biopsy device is shown and disclosed in U.S. Patent No. 5,526,822, U.S. Patent Application Serial No. 08 / 386,941, filed February 10, 1995, and U.S. Patent Application Serial No. 08 / 568,143, filed December 6, 1995. this known under the trade name Mammotome Biopsy system ^® device has the ability to actively take tissue before cutting through the fabric. Active uptake allows sampling by non-homogenous tissues, meaning that the device is equally capable of cutting hard and soft tissue. The apparatus includes a disposable probe, a motorized drive unit, and an integrated vacuum source. The probe is made of stainless steel and molded material and is designed to collect multiple tissue samples once the probe is inserted into the tissue. The tip of the probe is configured with a laterally arranged sampling notch for collecting tissue samples. The orientation of the sample score is made by the physician using a thumbwheel to guide the sampling in any direction around the circumference of the probe. A hollow cylindrical cutter cuts and transports tissue samples into a tissue sample collection chamber for later inspection.

While that MAMMOTOME biopsy system very good as a core biopsy device works, there are situations where it is due to the size of a lesion or whose location may be advantageous, a core biopsy device of U.S. Patent No. 5,111,828 to Kornberg et. al. disclosed type, here also explicitly as a reference, to use where the tissue receiving opening at the distal End of the device arranged and not laterally, but axially is aligned. However, a disadvantage of this type of device is in the missing ability before and during of tissue cutting effectively and efficiently in the tissue To draw the receiving chamber. A second disadvantage is the need to withdraw the device from the stem tissue and the first sample remove, reassemble the device and this then for any desired sample reintroduce. A third disadvantage is the need for manual Handling of each sample taken.

In Other situations can make the skill important be samples from any selected area of a cavity wall from the inside of the cavity, for which the use of a flexible Probe is required.

Furthermore, it is during the biopsy Wün desirable to determine the stage of the spread of a cancer. For example, breast cancer starts in the milk ducts, the mammary glands. The onset of atypical ductal hyperplasia is considered to be the beginning of the transition to breast cancer. The next stage is assumed to be ductal in situ carcinoma. Finally, the last stage in the development of breast cancer is infiltrating ductal carcinoma. When breast cancer has reached this stage of infiltrating ductal carcinoma, breast cancer cells have already developed the ability to migrate from the original duct, dissociate from each other, and invade vascular structures such as the lymphatic channels. When these malignant infiltrating ductal carcinoma cells invade the vascular system, they can spread to or metastasize to other parts of the body. This metastatic process ultimately leads to death from breast cancer.

If Breast cancer cells invade the lymphatic system, metastasize them in an orderly fashion into regional lymph nodes. A drain can be in the axillary lymph nodes, the supraclavicular lymph nodes, the lateral ones Thoracic lymph nodes and the internal thoracic lymph nodes are performed.

Currently is it common in practice to determine if breast cancer cells are in regional lymph nodes have spread by a known as lymphadenectomy surgical Axillary lymph node dissection is performed. In this open surgical Intervention becomes a relatively large one Cut (5-10 cm) in the axilla (the armpit) appropriate. This incision becomes a relatively large volume (15 to 30 grams) taken from adipose tissue and lymph node tissue.

During this Process can between 10 and 30 lymph nodes were taken and forwarded to the pathology Be where each of these lymph nodes point to the presence or absence of metastatic breast cancer is examined. For positive results In lymph node examinations, the breast cancer patient becomes a systematic Therapy, including Chemotherapy, subjected. If the lymph nodes of the axilla, however free of metastatic disease, the application is carried out limited to systematic therapies.

at surgical lymphadenectomy, mortality risk is low, however, the risk of disease is high. The most common cause of the disease is the development of lymphedema in the arm, ipsilateral to the axilla in which the dissection was performed. The development of lymphedema The ipsilateral arm is sometimes a debilitating complication. Another frequent Complication of surgical lymphadenectomy is the injury of sensory nerves in the incision area, resulting in a permanent sensory loss in the patient and often lead to a dislocation called "wing capsule".

at the study of lymphatic drainage of melanoma and now in the Lymphatic drainage of breast cancers was demonstrated that lymphatic drainage pattern by the injection of a radioisotope (or other marker, such as blue dye) immediately adjacent to the tumor can be. The isotope (or dye) is then either visually with a Gamma camera system or with a Geiger counter-like counting system tracked.

The Spread of cancerous cells is ordered, with the first lymph node, that of the drainage channels of the infected breast is reached, which contains most cancer cells. As a result, the first lymph node in the drainage system is referred to as the "sentinel lymph node".

Farther has been shown by easy removal of the sentinel lymph node without excision of the remaining lymph nodes in the axilla can be whether breast cancer in the regional lymph nodes of the axilla metastatic or not. The surgical removal of only a lymph node reduces the complications of lymph node surgery, including the development of lymphedema, to a great extent.

It would be desirable the risk of disease in axillary lymph node biopsy by providing of instruments that make it possible the sentinel lymph node with one as possible low impact on the surrounding tissue structure percutaneously identify and remove, continue to lower. The in this Patent described device can be percutaneously through a small Skin opening introduced and to the sentinel lymph node which eliminates open surgical exploration. As a result, could the sentinel lymph node biopsy performed on an outpatient basis which makes hospitalization unnecessary would be and the recovery time would be shorter.

A percutaneous sentinel lymph node biopsy is composed of the following elements: A radioisotope (for example, Technicium-99m-labeled sulfur colloid) is injected into the tumor area in the chest, which travels to the sentinel lymph nodes through the lymphatic channels. The sentinel lymph node then becomes radioactively visible or "hot." The apparatus described below is capable of identifying or locating the radioactive lymph node by acoustic and other signals specifying when the device is adjacent to the sentinel lymph node. The device is furthermore able to characterize or "visualize" the surrounding tissue with its associated ultrasound segment It is important to identify the associated structures adjacent to the lymph nodes, because the axilla has relatively large blood vessels (arteries, veins). Using the combination of Geiger counter and ultrasound identification, the sentinel lymph node can be identified and biopsied on it without invading a large blood vessel or severing a large nerve.

by virtue of the very small entry point does not require stitching (the process takes place percutaneously), and the patient can with a simple patch over the Entry point in the axilla to be sent home. The following Day gets the patient reports the results of percutaneous sentinel lymph node biopsy which indicates whether in the sentinel lymph node in the outflow of affected breast is a metastatic disease or not.

Out In the prior art, instruments are known which are suitable could to perform some of the operations described above. For example, disclosed U.S. Patent No. 5,401,272 discloses an electrosurgical probe with extendable ones bipolar electrodes, and the US patent No. 5,111,828 to Kronenberg et. al. discloses a device for percutaneous excisional biopsy of the breast, a cannula, open distal and proximal ends and a sharp cutting surface at the distal end. In Kronenberg runs through the cannula a stiletto that also has a distal puncture end. A guidewire to locate is used to move the instrument to a biopsy site respectively. The cannula is moved distally to a desired To excise tissue sample, whereupon a downward leading element to the distal The end of the tissue sample is pushed and then moved proximally to the sample completely from the surrounding tissue to separate.

One major disadvantage of the Kronenberg approach is that with each Introduce of the instrument to the biopsy site in the patient's body only one Tissue sample can be taken. After pulling downwards Elements for separating the tissue sample is not possible to repeat the process as long as the instrument remains on site. Other devices for sampling in a biopsy are disclosed in WO 95/08945. However, these are not electrosurgical Art. They include a device with cutting elements through withdrawal the cutting elements in a cannula to cut.

The The present invention has these disadvantages and deficiencies Prior art devices do not have and provide a improved device for a percutaneous excisional biopsy of tissue ready. The present Invention can also be for others Purposes as for percutaneous biopsy can be used. For example, the device may used for general organ and tissue removal by a trocar be used to perform various laparoscopic procedures, including splenectomy, nephrectomy, Appendectomy and liver removal, perform. The device can also laparoscopically used by a trocar to abnormal To remove growth, such as polyps.

Summary the invention

The The present invention provides a tissue sampling device according to the invention of the definition of claim 1, compared to those currently available Probes offer many benefits. In connection with the removal of intact tissue samples will get better results unexpectedly due to a unique combination of cutting options, in particular the application of an extendable electrosurgical Cutting elements comprise, thereby an immediate transection the distal end of the tissue sample without affecting the surrounding tissue to enable. In addition, can the instrument according to the invention advantageously carried out this way be that sections of the instrument during a process in contact with the tissue or secretion (i.e. H. Blood) of the patient come, modular and for a single use are designed to facilitate replacement of these sections a new module for to allow a following process without having to clean and sterilize the instrument. The Versatility of the invention allows their use in many fields of application, including, for example, breast biopsies, intraoperative staging, laproscopic surgery and Lymphadenektromie.

In particular, in one aspect of the invention, there is provided a tissue sampling apparatus comprising a tubular body having a lumen for receiving a tissue sample, the tubular body having a distal end and a proximal end. Along an axial length of the tubular body is an electrosurgical cutting element, preferably a wire. The cutting element includes a distal cutting end and is axially displaceable between an axially extended position and an axially retracted position. The instrument is particularly suitable for axial cutting when the wire is withdrawn, as it is advanced distally through a region of tissue from which a Tissue sample is desired. When the wire is extended, it curves in a radial direction over a portion of the sloping surface of the distal end of the tissue sample such that during slow rotation of the tubular body, the curved distal end of the cutting wire cleanly separates the distal end of the sample from the remainder of the tissue without affecting the remaining tissue.

In Another aspect of the invention is a tissue sampling device provided a tubular body comprises which has a lumen for receiving a tissue sample and which a distal end and a proximal end, wherein the tubular body of disposable materials is made. The device further comprises an electrosurgical Cutting element disposed along an axial length of the tubular body is, and a housing to include a portion of the tubular body, the case comprises a lid section, which is relative to a body portion of the housing to open is. The tubular body is advantageously designed modular, so he between medical procedures by opening the lid portion of the housing removed and easily replaced by another tubular body module.

The Invention together with additional features and advantages of these are best obtained by using the following description in conjunction with the corresponding, accompanying, illustrative Drawing understandable.

Short description the drawing

1 is a perspective view of a first preferred embodiment of the tissue sampling instrument according to the invention;

2 Figure 3 is a side elevational view illustrating how a tissue specimen is inserted into the distal end of the in 1 penetrates the instrument according to the invention shown;

3 - 8th are schematic side views of the distal end of the in 1 illustrated inventive instruments sequentially illustrating the relative position of the electrocaustic cutter during a representative tissue sampling;

9 is an enlarged cross-sectional view of an in 1 labeled with the letter A portion of the distal end of the instrument according to the invention;

10 is a cross-sectional side view of the in 1 illustrated inventive instrument;

11 Figure 3 is a side cross-sectional view of a second preferred embodiment of the tissue sampling instrument of the invention;

12 is a perspective view of the in 11 illustrated embodiment of the invention;

13a and 13b are cross-sectional views illustrating the tubular portion of FIG 12 illustrated embodiment of the tissue sampling instrument in a single view;

14 is a perspective view of the in 11 illustrated embodiment showing the operation of the embodiment of the tissue sampling device as it approaches a tissue region from which the sample is to be taken;

15 FIG. 12 is a perspective view of a stand-alone scanning probe used in conjunction with the embodiments of FIG 1 as well as 11 can be used; and

16 . 16a and 16b FIG. 15 are perspective views of a multiple image probe used in conjunction with the embodiments of FIG 1 or 11 can be used.

description the invention

With more specific reference to 1 and 9 a first embodiment of the invention is shown below. The tissue sampling probe according to the invention 10 includes a tube 12 that is a lumen 14 having. A cutter channel 16 extends axially along the length of the outer wall 18 of the pipe ( 9 ). Axial through the cutter channel 16 extends an electro-caustic cutting wire 20 which preferably comprises an electrically conductive, shaped metallic memory wire, such as Nitinol, which has a proximal portion 22 and a distal section 24 having. The cutting wire 20 is preferably formed as a flattened round wire because the resulting rectangular shape, which stiffens the wire in the x-direction and makes it flexible in the y-direction, prefers resistive side forces that occur when the wire is twisted in the fabric.

The pipe 12 preferably comprises an inner layer 25 and an outer layer 26 ( 9 ), with the inner layer 25 preferably from one non-transmissive radiolucent or radiopaque biocompatible composite material, such as a tortuous epoxy-impregnated glass filament matrix material. Another possibility is the use of a hard polyethylene (HDPE), which is cross-linked with a high radiation dose, so that it behaves like a thermoset, not like a thermoplastic. The pipe 12 preferably has a round cross-section, although other tube shapes may be used. Advantageous properties of the preferred composite include low weight, high melting temperature, high dielectric properties, ductility, non-conduction, and machinability. An outer layer 26 can be used, wherein the outer layer preferably has a strong dielectric coating, which is around the outer diameter of the inner layer 25 is shrink wrapped. As the preferred material for the inner layer 25 easily machinable is the channel 16 preferably by machine into the outer surface of the inner layer 25 incorporated.

Proximal to the pipe 12 arranged is an actuator 27 , which is preferably a housing 28 , an immovable grip 29 , a cutter advancement slide button 30 and an operation switch 32 includes. As in 10 shown, closes the housing 28 an electric motor with variable speed 34 a via a connecting cord 36 connected to a power supply unit. The operation of the engine 34 drives interlocking gears 37 and 38 at what to the selected turning of the pipe 12 leads.

An important aspect of the invention is the use of an electrocaustic generator (not shown). The electrical energy from the electrocaustic (electrosurgical) generator is via an electrical line 40 to the cutter wire 20 guided and using the electrosurgical power switch 32 selected activated or deactivated. As in 10 illustrates is the electrical line 40 with an electrode feed collar 41 connected, which is an electrical contact brush 42 and an electrode ring 44 includes. A proximal end 46 the cutter wire (electrode) 20 is attached to the Elekrodenvorfahrkranz. Therefore, with distal movement of the cutter advancement slide button 30 the electrode 20 advanced distally. For safety reasons, the slide button 30 and the Elekrodenvorschubkranz 41 opposite the cable 40 , the brush 42 and the electrode ring 44 electrically isolated.

With reference to the embodiment of 1 the electro-acoustic generator is in use by means of the control switch 32 activated for electrical activation of the cutter wire. The desk 32 is preferably a momentary switch which is operated only when it is depressed and held by an operator. At the same time the switch releases 32 the engine 34 out to the tube 12 by means of the gearbox 37 . 38 to rotate at a relatively high speed. Subsequently, the tube 12 pushed by the operator through tissue to remove the desired tissue sample, with the cutter wire 20 in its retracted position, as in 3 shown. With the wire 20 Powered to act as an electrocaustic cutter cuts through the advanced rotating tube 12 easily take the tissue to a tissue sample 48 ( 1 ) for inclusion in the lumen 14 to create. In the preferred embodiment, axially along the outer surface of the tube 12 Depth markers (not shown) may be appropriate to assist the physician in determining when the tube is 12 was advanced to the desired position.

In its preferred embodiment, the powered conductive cutter wire is used 20 to a tissue sample 48 to define and cut out the approximately the same inner diameter or approximately the same cross-sectional shape as the tube 12 having. The distal end of the tube 12 picks up the generally cylindrical tissue sample produced by simultaneously feeding, rotating, and advancing the tube and cutter wire. After a sample of suitable length has been secured, the feed of the tube becomes 12 stopped and the cutter wire 20 by pushing the cutter advance push button distally 30 distal relative to the tube 12 advanced. The distal feed of the cutter wire 20 is consecutive in 4 . 5 and 6 illustrated. As in 6 is shown, the cutter wire 20 fully advanced so that the electrically powered distal end 24 is curved radially inward to a portion of the distal end 49 the tissue sample 48 separate ( 2 ). While the wire 20 in its fully advanced position, the tube becomes 12 at a relatively slow pace by operating the engine 34 Turned until the tube 12 at least 180 degrees in the in 7 illustrated position and preferably 360 degrees in the in 8th has turned position illustrated. To the pipe 12 Turning at the second slower pace can either be the switch 32 can be switched to a second operating position, or a second switch can be used. This slow rotation of the tube 12 allows the powered distal end 24 of the cutter wire 20 , the entire distal end 49 the tissue sample 48 to sever and thereby the entire sample 48 in the lumen 14 of the instrument 10 to absorb, as in 1 and 2 shown.

After taking the sample in the lumen 14 one or more additional samples may be taken and taken in the lumen, if desired. When the desired tissue samples have been taken, the instrument can be removed from the patient's body so that the tissue sample (s) can be removed and examined. To speed up tissue sampling, the inner surface of the tube 12 be provided with a coating to reduce the frictional contact between the tube and the tissue sample as it passes through the lumen 14 emotional.

Although in the preferred embodiment it is not necessary to use a suction source (vacuum) to actively route the tissue sample into the tubular body 12 it is appropriate and in some situations desirable to draw these in a similar manner as in the parent application serial no. 08 / 705,622 discloses to provide. In such a case, a vacuum pressure source would be used to pass through the lumen 15 draw a vacuum so that the vacuum pressure in the lumen pulls tissue from which a sample is to be withdrawn into the lumen while the electrosurgical cutting element 20 cuts the pulled-in tissue. The vacuum pressure may then serve to assist transport of the tissue sample proximally through the lumen to a tissue sample collection vessel.

In addition to the in 1 In the illustrated embodiment, many other embodiments may be used. For example, in 11 and 12 a modified, presently preferred embodiment shown, in which all the elements of those of the embodiment of 1 In this embodiment, a modified actuation system is employed, The modified actuation system comprises a first actuation switch 32a , arranged on a proximal surface of the handle 29a which is preferably a momentary switch (which is only triggered when it is depressed and held by the operator). The first operating switch 32a causes the engine 34a , the pipe 12 at a relatively high rotational speed, and at the same time feeds the cutter wire 20a for electrosurgical cutting. In addition, there is a cutter wire feed trigger 50 distally related to the handle 29a appropriate. The cutter wire feed trigger 50 is over a pivot pin 52 swiveling on a fork 54 mounted as in 11 and 12 and is at its upper end on an electrode feed plate 56 attached ( 11 ). Such attachment between the trigger 50 and the feed plate 56 can be done by any conventional known mechanical fastening system. The electrode feed plate in turn is slidable on a carriage shaft 58 and between an electrode carriage block 60 and a proximal surface 62 of the housing 28a arranged, with the car block 60 also sliding on the carriage shaft 58 is arranged. An upper section 64 of the car block 60 is immovable on the electrode feed ring 41a attached. A second operating switch 66 is on the trigger 50 arranged. The desk 66 is like the first switch 32a suitable for the cutter wire 20a to feed and at the same time the engine 34a for turning the pipe 12a however, when the second switch is actuated, the motor operates at a lower speed around the tube 12a to rotate at a relatively low rotational speed. On the cartwheel 58 between the carriage block and a distal section 70 of the housing 28a is a biasing spring 68 arranged to the car block 60 proximally bias so that the cutter wire (electrode) 20a is biased in its retracted position.

An advantageous feature of the embodiment of the invention 11 and 12 is that it is suitable for a modular design, so that the portions of the instrument, which come physically in contact with the tissue and / or blood of a patient during a medical procedure, can be removed and easily replaced by a medical practitioner. This modularity allows for faster reuse of the instrument for a different patient operation without the need for extensive cleaning and sterilization. In particular, the housing 28a designed so that it has a lid 72 comprising, by means of hinges 74 at the main body section 76 is attached so that the housing 28a is to open access to the entire pipe section 12a to enable. When closed, the lid is 72 through a snap-in latch 78 secured. Thus, the entire pipe section 12a , as in 13a and 13b illustrates between the operations of a handy doctor or assistant easily in the housing 28a of the instrument 10a be installed or removed from it. The entire pipe section 12a including the electrode feed ring 41a and the transmission 38a , is preferably made of disposable materials, such as biocompatible plastics or composites, so that it can be disposed of after a single use at a reasonable cost.

With reference to 11 - 13b For example, a practitioner who wants to remove a particular tissue specimen from a patient can grasp the handle when in use 29a of the instrument 10a include and the instrument 10a move toward the intended entry point on the patient's body using known imaging techniques. While the distal end of the tube 12a approaching the entrance to the patient's body, the switch becomes 32a operated by the practitioner depresses and holds this so that the cutter wire 20a fed and at the same time the engine 34a for relatively fast rotation of the tube is caused to improve the cutting process. During the following period, the instrument is pushed further through the tissue of the patient, with the cutter wire 20a through the spring 68 is biased in its retracted position, as in 13a illustrated until a tissue sample 48a of desired length in the lumen 14a of the pipe 12a is included. While the wire 20a fed and withdrew and the pipe 12a rotates at a relatively high rotational speed, the entire distal end of the tube works 12a effectively as a cutting element for easy removal of a tissue sample core from the desired tissue area. Again, as with the first embodiment, depth markers (not shown) may extend axially along the outer surface of the tube 12a be attached to assist the practitioner in determining when the tube 12a was advanced to the desired position.

In its preferred mode of use, the powered conductive cutter wire is used 20a to a tissue sample 44a cut out the approximately the same diameter or approximately the same cross-sectional shape as the inner diameter of the tube 12a having. After a sample of suitable length has been secured, the feed of the instrument becomes 10a stopped and the cutter wire 20a by depressing the cutter wire feed trigger 50 advanced so that he from the in 11 shown position proximal to the guide peg 52 in the in 12 shown position pivots. This pivoting movement causes the electrode feed plate 56 to a distal movement, causing them to come into contact with the car block 60 comes and this also distally against the bias of the spring 68 pushes. This movement of the car block 60 in turn causes the electrode feed collar 41a to a distal sliding movement, causing the electrode (cutter wire) 20a into its extended position, as in 12 and 13b shown. The contact of the electrode feed plate 56 with the fork 54 serves as a stop to ensure that the cutter wire 20a Only over a desired distance is moved to the curved section 24a for severing the distal end of the sample 48a to create.

While the fingers of the practitioner trigger the trigger 50 and this to advance the cutter wire 20a Press down proximally, is advantageous at the same time the switch 66 depressed and thereby the engine 34a for turning the pipe 12a caused by a relatively slow rotational speed, in contrast to the relatively high rotational speed, by operating the switch 32a is triggered. Pressing down the switch 66 , which is preferably a momentary switch (such as switches 32a ), also simultaneously feeds the cutter wire 20a to produce electrosurgical cuttability. Applicants have found that the ability to advance the cutter wire distally 20a while slowly turning the tube 12a is advantageous for the procedure of tissue sampling, as compared to the alternative in which the wire is first extended to its advanced position and then the rotation of the tube 12a is initiated, which was originally considered necessary to by the rotation of the pipe 12 avoiding excessive side loads (torque) of the cutter wire as it is being extended.

After the cutter wire 20a fed and with relatively slow rotation of the tube 12a has been fully advanced to its extended position, is due to the operation of the switch 66 , as in 12 and 13b illustrates the fed distal end 24a of the wire 20a for cutting the entire distal end 49 the tissue sample 48a as in the 1 illustrated first embodiment. After transection, the sample is completely in the lumen 14a of the instrument 10a recorded ( 12 ), and the instrument can be withdrawn from the patient's body to take out the sample for examination. Alternatively, a vacuum source could be used to pull the tissue into the tube 12a and / or transporting the sample proximally through the tube 12a to assist in a tissue collection vessel (not shown).

To speed up the preparation of the instrument for another procedure on another patient, the lid may 72 of the housing 28a after taking out the sample 48a opened and the module used 12a separated from the instrument and disposed of as medical waste. Subsequently, a new module 12a installed in the enclosure and the lid secured in a closed position. Of course, the instrument can be used without sterilization or replacement of disposable be used on the same patient several times.

A particularly advantageous aspect of the invention is its utility in conjunction with scanning probes to identify and locate the desired tissue from which a sample is to be taken. For example, ultrasonic probes or radiation detection probes (Geiger counters) can be used as disclosed in U.S. Patent Nos. 4,959,547, 5,036,201, 5,119,818, 5,148,040, 5,170,055 and 5,246,005 issued to Care Wise Medical Products Corporation of Morgan Hill, California. With particular reference to 15 - 16b is that in 11 illustrated instrument 10a although it is represented by the in 1 illustrated instrument 10 or replaced by similar instruments. As in 11 . 12 . 13a and 13b Illustrated is the proximal end 78 of the pipe 12a open so that through the entire lumen 14a of the pipe 12a a line of sight from the proximal end 78 to the distal end of the tube 12a runs. The proximal end 78 may be configured to be a scanning probe 80 or 82 to record ( 15 and 16 ).

In 15 is an independent scanning probe 80 which may comprise either an ultrasound probe or a Geiger counter probe, both of which are well known in medical diagnostics. The probe 80 is specially configured to fit in the through hole 78 the device for removal of soft tissue 10a to fit. Electronic control lines 84 extend from a proximal end of the probe 80 associated control units for receiving and processing information obtained by the probe.

Alternatively, a multiple image probe, such as those shown in FIG 16 illustrated probe 82 , be used. This type of probe is capable of serving as both an ultrasonic probe and a Geiger counter probe and has two sets of control lines 86 and 88 for communication with the electronic control units of the ultrasonic or Geigerzählers on.

In use, a lesion (tissue) 90 from which a sample can be taken ( 15 ) using a multiple image probe 82 or a combination of standalone probes 80 localized in the device for removal of soft tissue 10a are arranged. The Geiger counter portion of the probe indicates an XY surface on the surface of the tissue from which a sample is to be taken, while the ultrasonic portion provides depth information and XY surface information. Subsequently, the device for removal of soft tissue 10a held in place while the scanning probe (s) is being removed. After removal of the scanning probe, a tissue sample can be removed by the methods described above.

While these Invention with regard to various specific examples and embodiments It is understood that the invention is not limited thereto limited is and that she is Within the scope of the following claims in various ways executable.

Claims (17)

Tissue sampling device ( 10 ), comprising: a tubular body ( 12 ), which is a lumen ( 14 ) for receiving a tissue sample and having a distal end and a proximal end, the lumen having a cross-sectional area; an electrosurgical cutting element ( 20 ), which along an axial length of the tubular body ( 12 ), wherein the cutting element ( 20 ) comprises a distal cutting end and an axially extended position and an axially retracted position relative to the tubular body ( 12 ) having; the distal cutting end of the electrosurgical cutting element ( 20 ) is slanted to extend over a portion of the cross-sectional area of the lumen (Fig. 14 ) when the cutting element is in the axially extended position and is not arranged to extend across the cross-sectional area of the lumen (FIG. 14 ) when the cutting element is in the axially retracted position, wherein the tubular body (10) 12 ) and the cutting element ( 20 ) are simultaneously rotatable for cutting. Tissue sampling device according to claim 1, characterized in that the electrosurgical cutting element comprises a wire. Tissue sampling device according to claim 2, characterized in that the Wire an electrically conductive, shaped metallic memory wire includes. Tissue sampling device according to claim 2 or 3, characterized in that the wire cross section a rectangular shape. Tissue sampling device according to one of the preceding claims, characterized in that the tubular body comprises an outer wall having a cutter channel disposed therein such that the electrosurgical cutting element is disposed within the cutter channel and so that when the cutting element is in its axially extended position, its distal end extending distally beyond a distal end of the cutter channel and, when the cutting element is in its axially retracted position, the entire distal end thereof disposed within the cutter channel. Tissue sampling device according to one of the preceding Claims, characterized in that the tubular body is constructed of an electrically non-conductive material. Tissue sampling device according to one of the preceding Claims, characterized in that the tubular body lumen is sized to receive a plurality of tissue samples. Tissue sampling device according to one of the preceding Claims, characterized in that the Device further comprises a coating on the inner surface of the tubular body includes to the carriage to allow the tissue samples to pass therethrough. Tissue sampling device according to one of the preceding Claims, characterized in that the Device further comprises depth marks on the tubular body, to allow the positioning of the device in a body of a patient. Tissue sampling device according to one of the preceding Claims, characterized in that the tubular body is rotatable with two different rotational speeds and that the Tissue sampling device further comprises a first operating switch for feeding the electrosurgical cutting element and for turning of the tubular body with a first higher rotational speed, when the electrosurgical cutting element retracts axially Position is located, and a second operating switch for dining the electrosurgical cutting element and for rotating the tubular body with a second lower rotational speed when the electrosurgical cutting element in the axially extended position. Tissue sampling device according to one of claims 1 to 9, characterized in that the Tissue sampling device further comprises a pivotable trigger, the is adapted to the electrosurgical cutting element in to move the axially extended position and at the same time the tubular body to rotate at a relatively low rotational speed. Tissue sampling device according to one of the preceding Claims, characterized in that the Tissue sampling device further comprises a housing having a lid portion which is relative to a remaining housing portion to open is, and that the tubular body out of the case removable for easy removal after a single use is. Tissue sampling device according to one of the preceding Claims, characterized in that the tubular body is made of non-expensive disposable plastic material. Tissue sampling device according to one of the preceding Claims, the tubular body is made of disposable materials and the device comprises: one casing to include a portion of the tubular body, the case comprises a lid section, which is relative to a body portion to open it is; the tubular body a rotary drive section for connecting to a rotary drive mechanism in the case to the selected Turning the tubular body comprises the tubular Body, which comprises the rotary drive section, removable from the housing is and medically through another tubular body between the medical operations is replaceable. Tissue sampling device according to claim 14, characterized in that the rotary drive mechanism a transmission comprises. Tissue sampling device according to claim 14 or 15, characterized in that the electrosurgical cutting element includes a wire, which is selected extendable and retractable along an axis of the tubular body is. Tissue sampling device according to claim 16, characterized in that a distal end of the wire extending in a direction which is substantially aslant lies to the axis, bends when the wire is extended distally.